New Delhi, Sep 27,2017 : Indian medical researchers on Tuesday announced success with a second rotavirus vaccine, which is expected to hit the market next month.
The vaccine to protect babies against a deadly form of diarrhoea comes at a time when the centre is expanding its immunisation basket with the inclusion of more shots.
Named Rotasil, the new vaccine has been made by a team comprising scientists from Serum Institute of India in collaboration with ten other outfits including non-governmental organisations PATH and Kolkata-based National Institute of Cholera and Enteric Disease.
Rotasil reduced severe rotavirus diarrhoea by more than a third – 39.5% over two years. Its efficacy was 55% against the most severe cases of rotavirus diarrhoea, which represent the highest risk of dehydration, hospitalisations, and deaths.
The results of the phase-III trials involving 7,500 infants have been published in the journal Vaccine on Tuesday.
“We are delighted with these results, which indicate that Rotasil, could save the lives of tens of thousands of children each year in India and, potentially, around the world,” said Rajeev Dhere, executive director of the Serum Institute, Pune.
Currently, there are three rotavirus vaccines available in India. Only one of them, Rotavac, made by Hyderabad-based Bharat Biotech, has been tested for efficacy in India. On a head-to-head comparison, Rotavac with 53.6% efficacy fared better than Rotasil that has 39.5% efficacy.
Asked whether 39.5% efficacy is good enough for the vaccine’s commercial marketing in India, a company official answered in affirmative.
“This result is in line with all other vaccines when tested in developing countries. All rotavirus vaccines show little lower efficacy in developing countries because of various reasons. But since the disease burden is very high, the impact of the same vaccine is tremendous,” Prasad Kulkarni, the lead investigator from Serum Institute told DH.
Nearly 37% of the 578,000 diarrhoeal deaths worldwide in children less than 5 years of age were caused by rotavirus in 2013, leading to 215,000 deaths out of which 22% were Indian kids.
It is estimated that in India alone,11.37 million episodes of rotavirus gastroenteritis occur every year, requiring 3.27 million outpatient visits and 872,000 inpatient admissions. Vaccination can prevent many of these hospitalisations.
In March 2016, the union health ministry introduced rotavirus vaccination in Haryana, Himachal Pradesh, Andhra Pradesh and Odisha. Later the scheme has been expanded to Assam, Tripura, Madhya Pradesh, Rajasthan and Tamil Nadu, increasing the vaccine market.
The ministry has placed an order for 3.8 million doses of Rotasil, whose cost is comparable to Rotavac. The other two vaccines, Rotarix (GSK) and RotaTeq (Merck) are more expensive.